Nos. 17-70810, 17-70817 NATIONAL FAMILY FARM …in the united states court of appeals for the ninth circuit nos. 17-70810, 17-70817 national family farm coalition, et al. petitioners,

IN THE UNITED STATES COURT OF APPEALS

FOR THE NINTH CIRCUIT

Nos. 17-70810, 17-70817

NATIONAL FAMILY FARM COALITION, ET AL.

Petitioners,

v.

U.S. ENVIRONMENTAL PROTECTION AGENCY, ET AL.

Respondents,

and

DOW AGROSCIENCES LLC,

Intervenor-Respondent.

NATURAL RESOURCES DEFENSE COUNCIL,

Petitioner,

v.

ANDREW R. WHEELER, ET AL.,

Respondents,

and

DOW AGROSCIENCES LLC,

Intervenor-Respondent.

______________________

On Petition For Review of Agency Action

of the United States Environmental Protection Agency

_______________________________

SUPPLEMENTAL BRIEF

OF U.S. ENVIRONMENTAL PROTECTION AGENCY, ET AL.

Case: 17-70810, 10/11/2019, ID: 11462051, DktEntry: 192-1, Page 1 of 73

Of Counsel:

Benjamin Wakefield

Michele Knorr

U.S. Environmental Protection

Agency

Office of General Counsel

Pesticides & Toxics Substances

Law Office

1200 Pennsylvania Avenue, NW

Washington, D.C. 20460

Oct. 11, 2019

Jonathan D. Brightbill

Principal Deputy Assistant Attorney General

Environment and Natural Resources Division

Michele L. Walter

Trial Attorney

J. Brett Grosko

Senior Trial Attorney

Environment and Natural Resources

Division

U.S. Department of Justice

999 18th Street

Suite 370, South Terrace

Denver, Colorado 80202

(303) 844-1345 (Walter)

(202) 305-0342 (Grosko)

[email protected]

[email protected]


iii

TABLE OF CONTENTS

TABLE OF AUTHORITIES ..................................................................................... v

TABLE OF ABBREVIATIONS ............................................................................... x

INTRODUCTION ..................................................................................................... 1

BACKGROUND ....................................................................................................... 2

EPA’s informal adjudication process to issue licenses for “pesticide

products.” ............................................................................................. 2

EPA’s licensing process looks at each active ingredient

in a pesticide product. .......................................................................... 5

EPA has discretion to issue an unconditional registration under

FIFRA Section 3(c)(5) or conditional registration

under Section 3(c)(7). .......................................................................... 9

ARGUMENT ........................................................................................................... 15

The 2014 Notice of Registration was unconditional under FIFRA

Section 3(c)(5) and NRDC has waived any argument to the

contrary. ............................................................................................. 15

EPA’s imposition of “conditions” on the registration has no bearing

on whether the registration actions were unconditional under Section

3(c)(5) or conditional under Section 3(c)(7). ..................................... 18

Neither EPA’s 2017 conditional Amendment nor the identification of

“outstanding data” during the 2017 registration process retroactively

changes the status of the previous unconditional registration actions

............................................................................................................ 19


iv

Substantial evidence supports the issuance

of the 2014 Registration. .................................................................... 22

EPA reasonably looked at 2,4-D and

glyphosate separately. .............................................................. 22

EPA’s regulations allow the Agency to determine whether to

do a new risk assessment based on whether a “new use” is

sought for an active ingredient. ............................................... 26

Consistent with EPA’s regulations, the Agency considered “all

relevant evidence” concerning the Enlist Duo registration

actions. ..................................................................................... 27

That Enlist Duo is intended to destroy weeds

(including milkweed) in the field does not render any

indirect effects on monarch butterflies an

“unreasonable adverse effect.” ................................................ 31

NRDC mischaracterizes EPA’s rationale for not

conducting a new risk assessment for glyphosate. .................. 32

Substantial evidence supports the 2017 conditional amendment. ..... 35

EPA’s volatility analysis is supported by numerous valid studies. ... 36

The Coalition’s argument concerning synergy is unsupported by the

statute and the record, both of which support EPA’s approach. ........ 38

The Coalition’s Critique of EPA’s Level of Concern-Risk

Quotient Method is Undercut by This Court’s Jurisprudence. .......... 42

The Court Should Defer to the Services and the EPA, not the

National Academy of Sciences, as to Which Methodology

Represents the “Best Available Science.”. ........................................ 45

The Court Should Not Rely on the Extra-Record

Biological Opinion and Evaluations that the Coalition Cites. ........... 49

The Coalition Waived and Lacks Standing to Raise, and the Court

Lacks Jurisdiction to Consider, the Coalition’s New Glyphosate

Argument............................................................................................ 51


v

TABLE OF AUTHORITIES

CASES

California ex rel. Lockyer v. U.S. Dep’t of Ag.,

575 F.3d 999 (9th Cir. 2009) ................................................................................44

Ctr. for Biological Diversity v. EPA,

847 F.3d 1075 (9th Cir. 2017) ..............................................................................57

Chevron, U.S.A., Inc. NRDC, Inc.,

467 U.S. 837 (1984) .............................................................................................21

City of L.A. v. U.S. Dep't of Commerce,

307 F.3d 859 (9th Cir. 2002) ................................................................................47

Conn. Fund for the Env't, Inc. v. EPA,

672 F.2d 998 (2d Cir. 1982) .................................................................................18

Fla. Power & Light Co. v. Lorion,

470 U.S. 729 (1985) .............................................................................................50

Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc.,

528 U.S. 167 (2000) .............................................................................................52

Friends of Santa Clara River v. Corps of Eng'rs,

887 F.3d 906 (9th Cir. 2018) ............................................................. 40, 42, 43, 51

Idaho Farm Bureau Fed. v. Babbitt,

58 F.3d 1392 (9th Cir. 1995) ................................................................................58

Karuk Tribe of California v. U.S. Forest Service,

681 F.3d 1006 (9th Cir. 2012) ...................................................................... passim

Lands Council v. Powell,

395 F.3d 1019 (9th Cir. 2005) ..............................................................................50

Lombardo v. Handler,

397 F. Supp. 792 (D.D.C. 1975), aff'd 546 F.2d 1043 (D.C. Cir. 1976) ..............46

Lujan v. Defenders of Wildlife,

504 U.S. 555 (1992) ................................................................................ 52, 53, 55


vi

N. Plains Res. Council, Inc. v. Surface Transp. Bd.,

668 F.3d 1067 (9th Cir. 2011) ..............................................................................16

NRDC v. EPA,

735 F.3d 873 (9th Cir. 2013) ................................................................................59

NRDC v. EPA,

857 F.3d 1030 (9th Cir. 2017) ..............................................................................59

Nuclear Info.and Res. Serv. v. NRC,

457 F.3d 941 (9th Cir. 2006) ...............................................................................55

Pollinator Stewardship Council v. EPA,

806 F.3d 520 (9th Cir. 2015) ................................................................................58

Reckitt Benckiser, Inc. v. EPA,

613 F.3d 1131 (D.C. Cir. 2010).............................................................................. 3

Rizk v. Holder,

629 F.3d 1083 (9th Cir. 2011) ..............................................................................51

Sw. Ctr. For Biol. Div. v. U.S. Forest Service,

100 F.3d 1443 (9th Cir. 1996) ..............................................................................44

Tritz v. U.S. Postal Serv.,

721 F.3d 1133 (9th Cir. 2013) ..............................................................................54

Weyerhauser v. FWS,

139 S. Ct. 361 (2018)............................................................................................46

Wisc. Elec. Power Co. v. Reilly,

893 F.2d 901 (7th Cir. 1990) ................................................................................21

Woodstream Corp. v. Jackson,

845 F. Supp. 2d 174 (D.D.C. 2012) .....................................................................18

STATUTES

5 U.S.C. § 551(6) ...................................................................................................3, 4

5 U.S.C. § 551(8) ....................................................................................................... 4


vii

5 U.S.C. § 551(13) ..................................................................................................... 4

7 U.S.C. § 136a-1(a) ................................................................................................23

7 U.S.C. § 136a(a) ...................................................................................................... 2

7 U.S.C. § 136a(c)(1)(C) ............................................................................................ 2

7 U.S.C. § 136a(c)(5) .................................................................................... 9, 10, 21

7 U.S.C. § 136a(c)(5)(B) ..........................................................................................39

7 U.S.C. § 136a(c)(7) ...............................................................................................10

7 U.S.C. § 136a(c)(7)(A) .........................................................................................11

7 U.S.C. § 136a(c)(7)(B) ............................................................................. 11, 12, 19

7 U.S.C. § 136a(g) ..................................................................................................... 7

7 U.S.C. § 136d(a)(2) ...............................................................................................30

7 U.S.C. § 136n(b) ..................................................................................................... 3

16 U.S.C. § 1536(a)(2) ...................................................................................... 42, 56

REGULATIONS

40 C.F.R. § 152.3 ...................................................................................................2, 6

40 C.F.R. § 152.15 ..................................................................................................... 2

40 C.F.R. § 152.50(f)(3) ..........................................................................................30

40 C.F.R. § 152.111 ...................................................................... 7, 9, 19, 24, 27, 28

40 C.F.R. § 152.112 .................................................................................................27

40 C.F.R. § 152.112(b) ............................................................................... 27, 28, 35

40 C.F.R. § 152.117 ...................................................................................... 4, 13, 14

40 C.F.R. § 155.42(a) ................................................................................................. 8


viii

40 C.F.R. § 155.42(a)(3) ............................................................................................ 8

40 C.F.R. Part 158 ...................................................................................................... 6

40 C.F.R. § 158.1(a) ................................................................................................... 6

40 C.F.R. § 158.1(b)(3) .............................................................................................. 6

50 C.F.R. § 402.13 ...................................................................................................45

50 C.F.R. § 402.14 ...................................................................................................44

FEDERAL REGISTER NOTICES

48 Fed. Reg. 34,000 (July 26, 1983) ................................................................. 24, 35

65 Fed. Reg. 24,586 (Apr. 26, 2000) ......................................................................... 8

70 Fed. Reg. 40,251 (July 13, 2005) ............................................................... 7, 8, 29

71 Fed. Reg. 45,720 (Aug. 9, 2006)........................................................................... 3

84 Fed. Reg. 44,297 (Aug. 23, 2019).......................................................................53

OTHER AUTHORITIES

S. Rep. No. 95-334 (1977) .......................................................................................12

Federal Pesticide Act of 1978: Hearings on S. 1678 Before the Committee of

Agriculture, Nutrition, and Forestry, 95 Cong. 69 (1979) ...................................12

About Pesticide Registration, https://www.epa.gov/pesticide-registration/about-

pesticide-registration#registration. (last visited Oct. 7, 2019) ............................... 3

Pesticide Registration Manual: Chapter 1 - Overview of Requirements for

Pesticide Registration and Registrant Obligations,

https://www.epa.gov/pesticide-registration/pesticide-registration-manual-

chapter-1-overview-requirements-pesticide#unconditional.

(last visited Oct. 7, 2019). ...................................................................................... 9


https://www.epa.gov/pesticide-registration/about-pesticide-registration#registration


https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-1-overview-requirements-pesticide#unconditional


ix

Conditional Pesticide Registration, https://www.epa.gov/pesticide-

registration/conditional-pesticide-registration (last visited Oct. 7, 2019) ...........10

Annual Reports on PRIA Implementation,

https://www.epa.gov/pria-fees/annual-reports-pria-implementation.

(last visited Oct. 7, 2019) .....................................................................................22

Beyond Pesticides, Health and Environmental Groups Call on EPA to Revoke

Glyphosate's Registration,

https://beyondpesticides.org/dailynewsblog/2019/09/health-and-environmental-

groups-call-on-epa-to-revoke-glyphosates-registration/

(last visited Oct. 11, 2019) ...................................................................................29

Interim Report to Congress on Endangered Species Act Implementation in

Pesticide Evaluation Programs (Nov. 2014),

https://www.epa.gov/sites/production/fi07/documents/esareporttocongress.pdf.

(last visited Oct. 7, 2019) .....................................................................................41

Interim Approaches for National-Level Pesticide Endangered Species Act

Assessments Based on the Recommendations of the National Academy of

Sciences (Apr. 2013), https://www.epa.gov/sites/production/files/2015-

07/documents/ interagency.pdf. (last visited Oct. 7, 2019) ..................................41

Biological Opinion Concerning the EPA’s Registration of Pesticides Containing

Chlorpyrifos, Diazinon, and Malathion (2008),

https://www.fisheries.noaa.gov/national/consultations/pesticide-consultations.

(last visited Oct. 8, 2019) .....................................................................................50

Biological Evaluation Chapters for Chlorpyrifos ESA Assessment,

https://www.epa.gov/endangered-species/biological-evaluation-chapters-

chlorpyrifos-esa-assessment; (last visited Oct. 8, 2019) ......................................51

Biological Evaluation Chapters for Malathion ESA Assessment,

https://www.epa.gov/endangered-species/biological-evaluation-chapters-

malathion-esa-assessment. (last visited Oct. 8, 2019) ..........................................51

Docket for Center for Biol. Div., et al. v. EPA, 3:11-cv-293 (N.D. Cal.),

https://www.regulations.gov/ docket?D=EPA-HQ-OGC-2019-0478.

(last visited Oct. 8, 2019) .....................................................................................54


https://www.epa.gov/pesticide-registration/conditional-pesticide-registration


https://www.epa.gov/pria-fees/annual-reports-pria-implementation

https://beyondpesticides.org/dailynewsblog/2019/09/health-and-environmental-groups-call-on-epa-to-revoke-glyphosates-registration/


http://www.epa.gov/sites/production/fi


http://www.epa.gov/sites/prod


https://www.fisheries.noaa.gov/national/consultations/pesticide-consultations

https://www.epa.gov/endangered-species/biological-evaluation-chapters-chlorpyrifos-esa-assessment


https://www.epa.gov/endangered-species/biological-evaluation-chapters-malathion-esa-assessment


https://www.regulations.gov/%20docket?D=EPA-HQ-OGC-2019-0478

x

TABLE OF ABBREVIATIONS

APA Administrative Procedure Act

BE Biological Evaluation

EPA Environmental Protection Agency

ER Petitioners’ Excerpts of Record

ESA Endangered Species Act

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

FWS Fish and Wildlife Service

LOAEC Lowest Observed Adverse Effect Concentration

NMFS National Marine Fisheries Service

NOAEC No Observed Adverse Effect Concentration

RSBER Respondents’ Supplemental Brief Excerpts of Record

SBER Coalition Supplemental Brief Excerpts of Record

SER EPA’s Supplemental Excerpts of Record

USDA United States Department of Agriculture


1

INTRODUCTION

In response to the Court’s May 30, 2019, Order, both sets of Petitioners have

submitted supplemental briefs. As to the issues under the Federal Insecticide and

Rodenticide Act (“FIFRA”), Petitioners’ arguments either misstate or

misunderstand FIFRA and the Environmental Protection Agency’s (“EPA”)

longstanding process of issuing pesticide product licenses. Every registration

action that EPA took here for Enlist Duo is consistent with FIFRA and EPA’s

regulations. And every action is supported by substantial evidence.

Petitioners, the National Family Farm Coalition, Family Farm Defenders,

Beyond Pesticides, Center for Biological Diversity, Center for Food Safety,

Pesticide Action Network North America, Beyond Pesticides, Environmental

Working Group, and Center for Biological Diversity (collectively “Coalition”)

largely restate their Endangered Species Act (“ESA”) arguments. They criticize

EPA’s level of concern-risk quotient methodology and approach for defining the

action area as confined to the treated fields. Those arguments fail for the reasons

EPA has stated previously. They are based on a fundamental misunderstanding of

Karuk Tribe of California v. U.S. Forest Service, 681 F.3d 1006 (9th Cir. 2012) (en

banc) (“Karuk Tribe”).

The Coalition also asserts a new ESA argument concerning the glyphosate

component of Enlist Duo. It waived any right to do so, however, by not presenting


2

it in its opening brief, and lacks standing. Even if it were properly presented, it

would fail. The use of glyphosate on cotton and soybean crops that have been

genetically engineered to resist the herbicide is not a “new use” under FIFRA. So

no duty has arisen to consult as to glyphosate under the ESA.

BACKGROUND

FIFRA’s Statutory and Regulatory Scheme for Pesticide Product

Registration and Registration Review.

Each Petitioner has a fundamentally incorrect understanding of how FIFRA

and its implementing regulations work. EPA incorporates by reference its prior

discussion of FIFRA’s background, see Brief of U.S. Environmental Protection

Agency, et al. (“EPA Br.”) 4-7, and provides further explanation here.

EPA’s informal adjudication process to issue licenses for

“pesticide products.”

EPA registers “pesticide products” under FIFRA Section 3(a), 7 U.S.C.

§ 136a(a), and its implementing regulations. Under 40 C.F.R. § 152.15 (“Pesticide

products required to be registered”), “[n]o person may distribute or sell any

pesticide product that is not registered under the Act. . . .” (emphasis added). A

“pesticide product” is “a pesticide in the particular form (including composition,

packaging, and labeling) in which the pesticide is, or is intended to be, distributed

or sold.” 40 C.F.R. § 152.3 (emphasis added); see 7 U.S.C. § 136a(c)(1)(C)


3

(requiring draft label with application).1 The “composition” of a specific

“pesticide product” can include one or more “active ingredients.” EPA Br. 4. A

“pesticide product” that contains more than one “active ingredient” is a

“combination” pesticide product. Id.

EPA must issue a registration for a “pesticide product” before the product

can be sold or distributed. That “registration” is a “license that allows a pesticide

product to be distributed or sold for specific uses under specified terms and

conditions.” 71 Fed. Reg. 45,720 (Aug. 9, 2006) (emphasis added); see Reckitt

Benckiser, Inc. v. EPA, 613 F.3d 1131, 1133 (D.C. Cir. 2010) (“A FIFRA

registration is a product-specific license describing the terms and conditions under

which the product can be legally distributed, sold, and used.”).

The licensing process is an informal adjudication under the Administrative

Procedure Act (“APA”).2 Through this informal adjudication process, EPA issues

the pesticide product license, which is an “order” under the APA. See 5 U.S.C.

1 The label provides “clear directions for effective product performance while

minimizing risks to human health and the environment.”

https://www.epa.gov/pesticide-registration/about-pesticide-

registration#registration. (last visited Oct. 7, 2019)

2 If EPA elects to hold a public hearing for a pesticide product registration, that

does not convert the registration process into formal adjudication. Where, as here,

a public hearing was held, that fact is relevant only for jurisdictional purposes

under FIFRA Section 16. 7 U.S.C. § 136n(b).




4

§ 551(6) (defining “order” as “the whole or part of a final disposition . . . of any

agency in a matter other than rule making but including licensing[.]”; see also id.

§ 551(8) (defining “license” to include an “agency . . . registration . . . or other

form of permission”).3 That license is the only mechanism that gives the registrant

(and others) permission to sell or distribute the pesticide product.

FIFRA does not direct EPA to issue a license in any particular form. EPA

therefore, as a general matter, issues a “Notice of Registration” for the initial

pesticide product license. See 40 C.F.R. §152.117. That Notice of Registration is

the “final disposition” in the informal adjudicatory process. 5 U.S.C. § 551(6); see

EPA Br. 12, n.3. For amendments to existing licenses, EPA typically issues the

amendment in the form of a letter. 40 C.F.R. § 152.117. Until a registration or

amendment is granted, the registrant does not have a license to sell or distribute the

pesticide product. The license is the only final “agency action” as defined by the

APA that can be challenged. See 5 U.S.C. § 551(13) (defining “agency action” as

“an agency rule, order, license. . . .”).

The underlying rationales supporting the license are found in “Decision

Documents.” FIFRA does not require EPA to develop such Decision Documents

3 Because the term “order” seems to have created confusion in earlier briefing,

EPA will use the term “license” to more clearly convey the legal import of the

mechanism that allows a registrant to sell or distribute a “pesticide product.”


5

during the informal adjudication process. When such documents are developed,

however, they are used to inform the final disposition on the license or amendment.

Importantly, those Decision Documents are not the license and do not authorize the

distribution or sale of the pesticide product. Rather, they explain EPA’s

underlying rationale and analysis. So even when EPA signs a final Decision

Document supplying the rationale for a license or amendment, there is no license

for a registrant to sell the pesticide product until EPA actually issues a Notice of

Registration (license) or letter amending the license to an applicant.

EPA’s licensing process looks at each active ingredient in a

pesticide product.

When EPA receives a registration application for a pesticide product, the

Agency determines whether the pesticide product contains a single active

ingredient, or is a “combination” product. See generally ER844 (When “a

company submits an application for a new use on a product that contains two or

more active ingredients” that product is a “combination product.”).

EPA also determines whether the application seeks a “new use,” i.e., a use

that has not been previously registered, of any previously registered active

ingredient. A “new use” as it pertains to “a product containing a particular active

4 “ER” refers to previously filed “excerpts of record” and “SER” refers to

“supplemental excerpts of record.” Additional Excerpts of Record provided with

this Supplemental Brief are indicated with “RSBER.”


6

ingredient, means . . . [a]ny additional use pattern that would result in a significant

increase in the level of exposure, or a change in the route of exposure, to the active

ingredient of man or other organisms.” 40 C.F.R. § 152.3 (emphasis added).

[W]here a company submits an application for a new use on a product

that contains two or more active ingredients . . . and the use being

requested for this combination product is currently registered for one

or more of the active ingredients, the EPA only assesses the risks and

benefits of the active ingredient that does not currently have products

registered for that use.”

ER522 (emphasis added). When a license is sought for a combination pesticide

product, EPA evaluates each active ingredient to determine whether the same uses

are already registered in another pesticide product. If so, the risks and benefits for

that active ingredient with respect to that use have already been assessed. So no

new assessment is required.

If a “new use” is sought for an active ingredient, EPA will assess the risks

and benefits of that new use. This includes whether the Agency has all the

requisite data for that new use. FIFRA’s regulations provide the kinds of data and

information that EPA requires from applicants for the pesticide product registration

process. See generally 40 C.F.R. Part 158; 40 C.F.R. § 158.1(a). These

regulations state that EPA is not restricted in how it uses or evaluates the data and

information to make its registration decisions. Id. § 158.1(b)(3). Indeed, EPA’s

regulations establish that the Agency has the flexibility to determine what data

requirements are necessary on a case-by-case basis. See id. § 158.30(a).


7

Thus, EPA’s longstanding practice is to review pesticide products on a

“chemical-by-chemical” basis, i.e. on an active ingredient basis. EPA then

incorporates that review into the decision for the overall pesticide product. 40

C.F.R. § 152.111; see 70 Fed. Reg. 40,251, 40,253 (July 13, 2005).

The type of review chosen depends primarily on the extent to which

the relevant data base has been reviewed for completeness and

scientific validity. . . . Except for applications for registration of a new

active ingredient or in special cases where it finds immediate review

to be warranted, the Agency will not commence a complete review of

the existing data base on a given chemical in response to receipt of

any application for registration. Instead the Agency will review the

application using the criteria for conditional registration in FIFRA

[Section] 3(c)(7)(A) and (B).

40 C.F.R. § 152.111 (emphasis added).

Under this practice, when the application for a pesticide product contains an

active ingredient for which there is an “existing database” (a database that supports

a use that is already registered for that active ingredient) EPA does not conduct a

new analysis of that active ingredient. Nor do EPA’s regulations require additional

analysis beyond the analysis previously conducted to register that use. See ER2;

see also ER206 (in applications for combination products, “EPA only assesses the

risks and benefits of the active ingredient that does not currently have products

registered for that use.”).

EPA’s approach to separately consider each active ingredient fits with

FIFRA’s registration review process under Section 3(g). 7 U.S.C. § 136a(g).


8

During registration review, which takes place on a recurring 15-year cycle, EPA

“evaluate[s] elements of FIFRA 3(c)(5) including the composition, labeling and

other required material (including studies and other data), risks and benefits of a

pesticide, and incident data or other information relating to its use.” 65 Fed. Reg.

24,586, 24,587 (Apr. 26, 2000).

The purpose behind registration review is to account for “the rapid

development of science and the subsequent application of that knowledge in how it

impacts human health and the environment.” 70 Fed. Reg. at 40,252. Registration

review therefore “establishing ongoing scientific look-back procedures” to

consider for this “continually evolving” landscape. Id. at 40,253.

FIFRA Section 3(g), however, does not specify what “unit of review” EPA

should use in this process. 70 Fed. Reg. at 40,258. EPA’s regulations therefore

direct that registration review will be conducted for “one or more active

ingredients and all the products containing such ingredient(s).” 40 C.F.R.

§ 155.42(a); see 70 Fed. Reg. at 40,258. For a combination pesticide product, that

product will be assigned to the registration review case for each active ingredient.

40 C.F.R. § 155.42(a)(3).

During the registration review process, EPA may issue “data call-ins” for

active ingredients that are undergoing registration review. If EPA determines that

additional information is needed after receiving data in response to that data call-


9

in, EPA may determine that the data requirements for that data call-in are still

“outstanding.” As explained below, infra Section I.C., “outstanding data” in the

context of the registration review process are different from data that may be

missing from the requisite data needed to register a new use of an active ingredient.

EPA has discretion to issue an unconditional registration under

FIFRA Section 3(c)(5) or conditional registration under Section

3(c)(7).

EPA “has discretion to review applications under either the unconditional

registration criteria of FIFRA [Section] 3(c)(5) or the conditional registration

criteria of FIFRA [Section] 3(c)(7).” 40 C.F.R. § 152.111. FIFRA does not dictate

how EPA should exercise this discretion.

Unconditional registrations under FIFRA Section 3(c)(5), 7 U.S.C.

§ 136a(c)(5), can be granted for a variety of applications, including for “new uses”

or new active ingredients, as long as certain criteria are met. See

https://www.epa.gov/pesticide-registration/pesticide-registration-manual-chapter-

1-overview-requirements-pesticide#unconditional. (last visited Oct. 7, 2019).

Among the requirements for making a decision to issue an unconditional

registration under Section 3(c)(5), EPA must determine that the pesticide product

“will perform its intended function without unreasonable adverse effects on the

environment,” and that “when used in accordance with widespread and commonly




10

recognized practice, [the pesticide product] will not generally cause unreasonable

adverse effects on the environment.” 7 U.S.C. § 136a(c)(5); see EPA Br. 5.

EPA alternatively may issue a conditional registration under FIFRA Section

3(c)(7), 7 U.S.C. § 136a(c)(7). Prior to 1978, EPA could “register a pesticide only

if the Agency had sufficient data to show the pesticide would not cause

unreasonable adverse effects on human health and the environment when used

according to the use directions and restrictions provided on the pesticide product

label.” https://www.epa.gov/pesticide-registration/conditional-pesticide-

registration (“Conditional Registration Website”) (last visited Oct. 7, 2019). Under

that earlier standard, EPA “could not register a new pesticide unless its registration

application was supported by all the information required under then-current

scientific standards.” Id. “Because scientific standards evolve over time,

applicants seeking registration for new pesticide products were typically required

to provide significantly more data than had been required in the past for virtually

the same product. This led to an unfair situation.” Id. Thus, if EPA was

considering an application for Pesticide Product B, which was identical to or

substantially similar to currently-registered Pesticide Product A, EPA would need

to

deny registration if the data requirements had evolved to require

additional information that was not required when [P]roduct A was

registered. The grounds for the denial of registration for [P]roduct B

was that EPA lacked the data necessary to conclude that the new




11

product met the “no unreasonable adverse effects” on human health

and the environmental standard, even though an identical product,

[P]roduct A, was still allowed to be sold and used.

Id.

Congress remedied that situation in 1978. It added FIFRA Section 3(c)(7),

which gave EPA additional authority in two specific circumstances relevant here.

Under 3(c)(7)(A), EPA can “register a pesticide product ‘conditionally’ . . . if it

was identical or substantially similar to a currently registered product, even if there

were gaps in the data, as long as EPA could make the necessary statutory

findings.” Id.; see 7 U.S.C. § 136a(c)(7)(A). Pesticide products that EPA registers

under FIFRA Section 3(c)(7)(A) also are known as “me-too” products.

In addition, EPA can register a pesticide product under 3(c)(7)(B) “may

conditionally amend the registration . . . to permit additional uses” of the pesticide

active ingredient even if the “data concerning the pesticide may be insufficient to

support an unconditional amendment” so long as EPA makes certain findings.

Conditional Registration Website (specifying findings); see 7 U.S.C.

§ 136a(c)(7)(B). Under this conditional registration provision, the applicant must

submit or cite the same data that would be required for unconditional registration

of a similar product under FIFRA section 3(c)(5). 7 U.S.C. § 136a(c)(7)(B).

Through Section 3(c)(7), Congress intended to prevent the FIFRA

registration program from grinding “to a virtual halt” simply because of the fast


12

pace at which scientific data evolves. See EPA Br. 35 (quoting S. Rep. No. 95-334

at 3). Thus, Section 3(c)(7) gives EPA the flexibility to grant conditional

registrations when there are “outstanding data,” such as in the context of

registration review or that otherwise would warrant a denial of the registration.

Federal Pesticide Act of 1978: Hearings on S. 1678 Before the Committee of

Agriculture, Nutrition, and Forestry, 95 Cong. 69 (1979). Under Section 3(c)(7)

EPA “must find that satisfactory data pertaining to the new use have been

submitted. . . .” Id.; 7 U.S.C. § 136a(c)(7)(B). If so, the Agency may conditionally

register the new use. That new use is conditional under Section 3(c)(7) based on

any data concerning the active ingredient that are not yet generated, in review, or

outstanding for other reasons such as in the context of a data call-in during

registration review.

The Enlist Duo Registration and Amendments.

Because Enlist Duo is a combination “pesticide product” containing two

“active ingredients” – 2,4-D and glyphosate – EPA looked to whether the

application sought a “new use” for either of those active ingredients. Only 2,4-D

presented a “new use” in the Enlist Duo application. ER2-4. EPA therefore was

not required to conduct a new risk assessment for the existing registered uses of

glyphosate for any of the three registration actions for Enlist Duo. EPA Br. 11

(citing ER2-4).


13

Through the informal adjudication process, EPA issued a Notice of

Registration for its 2014 action, which is the initial license for Enlist Duo.

ER1401; 40 C.F.R. § 152.117. The 2014 Notice of Registration states that the

registration was “unconditional” under FIFRA Section 3(c)(5). ER1401. The

2014 Registration was unconditional because EPA determined that the pesticide

product met the standard, i.e., “no unreasonable adverse effects,” from FIFRA

Section 3(c)(5), and, at that time, there were no “outstanding data” identified for

2,4-D (the only active ingredient for which a “new use” was sought).

Consistent with that 2014 Notice of Registration, the Proposed Decision

Document also stated that the analysis EPA conducted for this registration action

supported the decision to grant an unconditional registration. RSBER27 (“Based

on these considerations, consistent with the requirements of FIFRA Sec. 3(c)(5),

EPA concludes that . . . approving this application as set forth below will not cause

any unreasonable adverse effect on the environment.”).

One document (the Final Decision Document) mistakenly refers to the 2014

registration as “conditional” (under FIFRA Section 3(c)(7)). ER1394-95. Except

for the typographical error in that one document, it is clear from the record as a

whole and from the substance of EPA’s actions that EPA applied the unconditional

registration standard to ensure that there were no “unreasonable adverse effects,”


14

and issued the registration under FIFRA Section 3(c)(5), as shown on the Notice of

Registration (the actual license).

A few months later, when EPA issued the 2015 Amendment for Enlist Duo

to add nine states, EPA still had not identified any outstanding data as to the new

use of 2,4-D. Thus, the status of that amendment was still unconditional under

Section 3(c)(5). Consistent with its regulation, see 40 C.F.R § 152.117, EPA

issued the 2015 amendment by letter approving the additional states, which was the

actual license. ER1019-40; see 40 C.F.R. § 152.117. The rationale supporting that

Amendment is in the 2015 Final Decision Document. ER1055-60.

By the time EPA granted the 2017 Amendment for Enlist Duo,

circumstances had changed. EPA determined that studies submitted in response to

a data call-in for 2,4-D as part of the FIFRA registration review process did not

fully satisfy the data call-in. Those studies therefore were considered “outstanding

data” for all registered uses of 2,4-D, and any further registration action on the

existing Enlist Duo license would have to be “conditional” under FIFRA Section

3(c)(7). The license for the 2017 Amendment is found at ER37 (Notice of

Registration) and specifically states that the amended registration is conditional


15

under Section 3(c)(7).5 ER37. The rationale supporting the 2017 Amendment is

found in the Final Decision Document. ER28-30.

ARGUMENT

EPA Properly Registered Enlist Duo In 2014 As An Unconditional

Registration And Subsequently Issued A Conditional Amendment To

That Registration, While Consistently Applying The Most Stringent

Standard To Its Actions.

Petitioner Natural Resources Defense Council (“NRDC”) demands that EPA

should have issued the 2014 Registration as unconditional under FIFRA 3(c)(5).

NRDC Suppl. Br. 2-8. That is exactly what EPA did. Regardless of whether the

2014 Registration was unconditional or conditional, however, EPA consistently

(with the exception of the one typographical error) used the most stringent

substantive standard (the standard under Section 3(c)(5)) to analyze whether Enlist

Duo would cause any “unreasonable adverse effects on the environment.”

The 2014 Notice of Registration was unconditional under FIFRA

Section 3(c)(5) and NRDC has waived any argument to the

contrary.

The 2014 Notice of Registration (the actual license) and the Proposed

Decision Document show that EPA was proceeding with an unconditional

5 EPA exercised its discretion to issue the license for the 2017 Amendment in the

form of a Notice of Registration instead of a letter given the remand of Enlist Duo

(without vacatur) in the previous litigation challenging the 2014 and 2015 actions.

(That litigation is referred to as Enlist Duo I, see EPA Br. 12 (providing case

citations)). EPA, however, could have exercised its discretion to issue that license

amendment in the form of a letter, as it did in 2015.


16

registration under Section 3(c)(5). Supra at 13. The Proposed Decision Document

also shows that EPA used the standard from 3(c)(5): “consistent with the

requirements of FIFRA [Section] 3(c)(5), EPA concludes that . . . approving this

application as set forth below will not cause any unreasonable adverse effects on

the environment.” RSBER27. This totality of circumstances refutes NRDC’s

argument that EPA improperly issued a conditional registration in 2014.6

Moreover, NRDC has waived any argument that EPA issued a conditional

registration in 2014. N. Plains Res. Council, Inc. v. Surface Transp. Bd., 668 F.3d

1067, 1081 (9th Cir. 2011) (“A party waives arguments that are not raised during

the administrative process.”). NRDC never raised this argument until its opening

brief in this current case. Indeed, when NRDC provided comments on the

proposed 2015 Amendment – after development of the 2014 Final Decision

Document and issuance of the 2014 Notice of Registration – and when NRDC

provided comments on the 2017 Amendment, it never purported any confusion or

argument about what type of registration was done in 2014 and never argued that

the 2014 Notice of Registration was conditional rather than unconditional.

ER1614-64.

6 For these same reasons, the Coalition’s argument that EPA “made a mess of

FIFRA’s registration standards,” is incorrect. Coalition Suppl. Br. 29.


17

Also, when NRDC challenged the 2014 Notice of Registration and 2015

Amendment in its petition for review in Enlist Duo I, it never argued that EPA

incorrectly registered Enlist Duo in 2014 under the conditional standard in (c)(7).

In fact, in supporting EPA’s motion for remand and vacatur of the 2014 Notice of

Registration and 2015 Amendment, NRDC cited only Section 3(c)(5) (and not

3(c)(7)) in discussing the 2014 Registration, thereby acknowledging that the 2014

registration was an unconditional registration. See generally ECF #125 (Case Nos.

14-73353, 15-71213 and consolidated cases) (repeatedly citing Section 3(c)(5)

instead of 3(c)(7) and acknowledging that the standard EPA applied was the

“unreasonable adverse effects on the environment” standard from 3(c)(5)).

NRDC’s merits brief in Enlist Duo I also did not make any argument that the 2014

Notice of Registration was an improper conditional registration. ECF #106 (Case

Nos. 14-73353, 15-71213 and consolidated cases).

Regardless, this belated argument that NRDC conjured up for the first time

in this litigation is a red herring. Even if the Court adopts NRDC’s position that

EPA issued a conditional registration in 2014, the record shows that EPA applied

the substantive standard from the unconditional registration provision. See supra

at 13. NRDC and EPA agree that this is the more stringent standard. NRDC

Suppl. Br. 7. Thus, any supposed error by EPA was harmless, as EPA’s analysis at


18

the time of the 2014 Notice of Registration would not have been different even if

that registration had been thought to be conditional rather than unconditional.

EPA’s imposition of “conditions” on the registration has no

bearing on whether the registration actions were unconditional

under Section 3(c)(5) or conditional under Section 3(c)(7).

“EPA routinely places a variety of conditions on registrations.” Woodstream

Corp. v. Jackson, 845 F. Supp. 2d 174, 181 (D.D.C. 2012). Indeed, nothing in

FIFRA precludes EPA’s authority to place conditions on pesticide product

licenses. See id. at 180 (deferring to EPA’s interpretation of FIFRA that EPA has

the “authority to place conditions on pesticide registrations other than those

specified in Section 3(c)(7)”). “The plain language of the statute does not restrict

EPA’s authority as to the type of conditions that may be placed on registrations.”

Id. As a practical matter, courts have recognized agency “authority to issue

licenses or registrations subject to conditions.” Id. at 181 (citing Conn. Fund for

the Env’t, Inc. v. EPA, 672 F.2d 998, 1006 (2d Cir. 1982)).

EPA’s imposition of such conditions (which are unrelated to data

requirements) on the registration balances the risks and benefits of the pesticide

product. Those conditions, however, are not the same as issuing a “conditional”

registration or amendment under FIFRA Section 3(c)(7). These conditions may be

included on either an unconditional or a conditional registration or amendment.


19

NRDC’s reliance on “conditions” that EPA imposed on the registration in

issuing the 2014 license therefore has no relevance to whether the 2014 Notice of

Registration was an unconditional or conditional registration. NRDC Suppl. Br. 4.

In this case, EPA placed conditions on the registration concerning possible future

weed resistance. ER102-3. Placing these conditions on the 2014 unconditional

registration (and the amendments to that registration) was well within EPA’s

authority to ensure the action being granted met the registration standard. But it

has no bearing on whether the registration actions were unconditional under

Section 3(c)(5) or conditional under Section 3(c)(7).

Neither EPA’s 2017 conditional Amendment nor the identification

of “outstanding data” during the 2017 registration process

retroactively changes the status of the previous unconditional

registration actions.

NRDC further argues that because the 2017 Amendment was a conditional

amendment under Section 3(c)(7) and because EPA’s 2017 action did not change

the 2014 Registration or 2015 Amendment, that must mean that the 2014

Registration also was conditional under Section 3(c)(7). NRDC Suppl. Br. 5.

NRDC’s revisionist history is incorrect. EPA has the discretion to change the

status of a registration from unconditional to conditional. 40 C.F.R. § 152.111.

Indeed, the purpose behind Section 3(c)(7)(B) is to authorize this exact scenario

where an unconditional registration may be conditionally amended because of

evolving science and data. 7 U.S.C. § 136a(c)(7)(B).


20

NRDC also argues that once EPA determined that there were “outstanding

data” during the 2017 Amendment process, the Agency was barred from

“reissuing” its 2014 and 2015 actions. NRDC Suppl. Br. 22-23. NRDC’s

argument is based on flawed logic that EPA “reissued” its approvals of the 2014

Registration and 2015 Amendment. Id. EPA does not “reissue” registrations or

amendments; rather, EPA amends an existing license.

Here, when EPA issued the Enlist Duo license in 2014 and amended the

license in 2015, those actions were unconditional because EPA was not aware of

any “outstanding data” in the context of registration review for 2,4-D. But, when

EPA issued the amendment in 2017, circumstances had changed. The Agency was

then aware of outstanding data in the context of registration review with respect to

the use of 2,4-D across all registered pesticide products. That 2017 Amendment

therefore was conditional. The entire Enlist Duo license, as amended, is now

conditional. That does not mean that the unconditional 2014 Registration and 2015

Amendment were invalid or that they were retroactively converted to a conditional

registration and amendment. The entire Enlist Duo license, which incorporates the

2014 registered uses and the 2015 amendment, is now conditional under Section

3(c)(7) based on the existence of that “outstanding data” for 2,4-D in the

registration review process.


21

Substantial Evidence Supports Each Registration and Amendment

Action.

FIFRA is silent on how EPA must conduct risk assessments to balance the

risks and benefits in determining whether to register a pesticide product. EPA

therefore has discretion in weighing the risks and benefits associated with a

pesticide product to ensure that there are “[no] unreasonable adverse effects.” 7

U.S.C. § 136a(c)(5). In a “complex regulatory scheme” like FIFRA, the Court

should give deference to EPA’s interpretation of how to exercise this discretion.

See Wisc. Elec. Power Co. v. Reilly, 893 F.2d 901, 906-07 (7th Cir. 1990); see also

Chevron, U.S.A., Inc. v. NRDC, Inc., 467 U.S. 837, 865 (1984) (giving deference

to agency interpretation where “regulatory scheme is technical and complex”).

Throughout each registration action for Enlist Duo, EPA used the more

stringent standard from FIFRA’s unconditional registration provision in Section

3(c)(5) to determine whether Enlist Duo would cause any “unreasonable adverse

effects.” NRDC does not dispute that this standard is more stringent than the

standard in 3(c)(7).7 Thus, the only question is whether, under that more stringent

3(c)(5) standard, EPA’s record contains substantial evidence to support the Enlist

Duo registration and amendments. The answer is yes.

7 The Coalition disputes that the 3(c)(5) standard is more stringent, but EPA

demonstrated why the Coalition is wrong. EPA Br. 33-37.


22

Substantial evidence supports the issuance of the 2014

Registration.

EPA reasonably looked at 2,4-D and glyphosate separately.

During a registration action, EPA will not conduct a new risk assessment for

a currently-registered active ingredient just because new science has emerged since

the last registration for the same uses of that active ingredient. The appropriate

place for that analysis is in the context of the FIFRA Section 3(g) registration

review. That is where all uses associated with a particular active ingredient will be

assessed across all pesticide products containing that active ingredient.

This approach is not only consistent with the statute, but makes practical

sense as well. In the more than 2,000 registration actions EPA takes each year,

hundreds of them include applications for pesticide products that contain active

ingredients that are already registered for the same uses. See

https://www.epa.gov/pria-fees/annual-reports-pria-implementation. (last visited

Oct. 7, 2019). Given the continuous development of scientific studies about active

ingredients, it would be impracticable to demand that EPA must review all new

scientific information that has been developed for every new application since the


https://www.epa.gov/pria-fees/annual-reports-pria-implementation

23

last time an active ingredient was registered for the same uses.8 Instead, the proper

place for that updated review is in the context of Section 3(g) registration review.

To further illustrate the reasonableness of EPA’s approach looking

separately at each active ingredient, consider an application for a pesticide product

that contains only one active ingredient. If the uses of that active ingredient have

already been registered in other pesticide products, nothing in FIFRA requires EPA

to conduct a new risk assessment based on scientific data that was developed after

the last registration. Indeed, that approach would eviscerate Congress’ concern

(addressed in Section 3(c)(7)) about creating an uneven playing field between

existing registrations and new registrations. See supra 10-12.

Contrary to this longstanding process, NRDC argues that EPA cannot

separately examine each “active ingredient” in a combination pesticide product.

NRDC Suppl. Br. 14-15. To that end, NRDC narrowly focuses on the definition of

“pesticide,” under the statute. It argues that the statute requires EPA to “analyze

the entire pesticide” instead of taking an active-ingredient-by-active-ingredient

8 EPA’s approach in this regard also is consistent with FIFRA Section 4 (the re-

registration program). Under that Section, EPA reregistered “each registered

pesticide containing any active ingredient contained in any pesticide first

registered before November 1, 1984 . . . .” 7 U.S.C. § 136a-1(a) (emphasis added).

Consistent with the reregistration approach, under FIFRA section 3(c), EPA looks

to each active ingredient in a pesticide product when registering or amending that

pesticide product in the first instance.


24

approach. Id. at 14. NRDC’s approach ignores the statutory definition of

“pesticide,” as compared to the definition of the regulatory definition of “pesticide

product,” and EPA’s longstanding practice to separately analyze each active

ingredient. See supra at 5-8; see also 40 C.F.R. § 152.111.

If NRDC’s approach were used, there would be no point to reevaluating all

uses for an active ingredient in the FIFRA registration review under Section 3(g).

Nor would there be a reason for Congress to have allowed issuance of “me-too”

registrations under FIFRA Section 3(c)(7)(A). See supra at 5-8. Further, an active

ingredient that has been registered for the same uses would be held to different

scientific review standards each time a new application is submitted for those same

uses. That would eviscerate Congress’ intent behind FIFRA section 3(c)(7).

NRDC’s approach would hold new applicants to a higher standard than previous

applicants and create vast inconsistencies in regulatory decisions for the same

active ingredient. It would also play havoc with EPA’s ability to establish

registration review schedules for orderly review of different active ingredients:

If the Agency were required to conduct an in-depth review of all data

on a pesticide each time an applicant requested unconditional

registration, EPA would lose control over the order in which it

reviewed chemicals. Instead, the order would be determined by the

sequence in which companies submitted applications.

48 Fed. Reg. 34,000, 34,001 (July 26, 1983).


25

To illustrate the illogical nature of NRDC’s argument, consider that in 2014,

Intervenor-Respondent Dow Agrosciences LLC (“Dow”) could have sought to

register just the new uses of 2,4-D rather than the combination of 2,4-D and

glyphosate in Enlist Duo. In that case, EPA could have originally registered a 2,4-

D product that included the ability to tank mix it with other glyphosate pesticide

products that have long been registered for these same uses. The result in that

situation and in the situation of the actual combination product that was registered

in 2014 would be the same: EPA would be concerned only with the unregistered

new uses of 2,4-D, and not with the already registered uses of glyphosate.9

It is important to know, however, that EPA did analyze the entire pesticide

product formulation for Enlist Duo. See SER460, 479 (field studies conducted on

several combinations including 2,4-D choline and glyphosate). This is particularly

evident in EPA’s consideration after the remand in Enlist Duo I of whether there is

synergy between 2,4-D and glyphosate (which there is not). ER4-5. So just as

9 Although glyphosate itself has been registered for decades, see EPA Br. 11, the

particular type of glyphosate used in Enlist Duo has been registered since 2007 in

another pesticide product for these same uses and on these same crops. See

RSBER33-171 (note this is “GF Registration 1280,” not “GS Registration 1230” as

indicated in the certified index). Thus, if a registrant submits an application for a

pesticide product that only contains glyphosate as the active ingredient and there is

no “new use” sought for glyphosate, EPA can issue a “me too” registration for that

product. Here, EPA reviewed glyphosate “as if” the Agency was reviewing it as a

me too application, ER3-4, 84, but because the only new action was the “new use”

for 2,4-D, EPA did not have an obligation to fully explain that process.


26

NRDC demands, EPA “analyze[d] the risks associated with this entire mixture.”

NRDC Suppl. Br. 15. NRDC’s real complaint is with the type of analysis that

EPA did and whether EPA was required to conduct a new full-blown risk

assessment for the already-registered uses of glyphosate. Neither the statute nor

regulations require EPA to do any such thing.

EPA’s regulations allow the Agency to determine whether

to do a new risk assessment based on whether a “new use”

is sought for an active ingredient.

NRDC errs further in arguing that EPA must consider all existing evidence

of Enlist Duo’s risks regardless of whether the active ingredients have a “new use”

and, thus, that “new use” is irrelevant. NRDC Suppl. Br. 16-17. For the reasons

discussed above, see supra at 7-10, NRDC’s interpretation would defeat the

purpose of registration review and is not supported by the statute, congressional

intent, or EPA’s regulations.

NRDC further argues that EPA lacked substantial evidence to conclude that

Enlist Duo would not entail any “new use” of glyphosate. Id. at 17-18. NRDC is

wrong. The simple fact – undisputed by any evidence – is that this same form of

glyphosate has been registered for these same over-the-top uses on corn, soybeans,

and cotton since 2007, and glyphosate itself has been registered for these same

uses for decades. See supra n.9.


27

Consistent with EPA’s regulations, the Agency considered

“all relevant evidence” concerning the Enlist Duo

registration actions.

EPA agrees with NRDC that under the Agency’s regulations, EPA must

consider “all relevant evidence” before granting an unconditional registration.

NRDC Suppl. Br. 24; 40 C.F.R. § 152.112(b). EPA did just that. Under 40 C.F.R.

§ 152.112, EPA will approve an application under FIFRA Section 3(c)(5) “only if .

. . [t]he Agency has reviewed all relevant data in the possession of the Agency.”

Id. § 152.112(b).10 Where EPA disagrees with NRDC is regarding the scope of the

term “relevant.”

NRDC’s argument in this regard focuses only on studies concerning

glyphosate – not 2,4-D. Its argument is based on the mistaken notion that EPA

was required to conduct an entirely new risk assessment for the same uses of

glyphosate in Enlist Duo that have already been registered numerous other times.

As discussed above, no such requirement exists. See supra at 7. The language in

40 C.F.R. § 152.112(b) does not require EPA to review emerging scientific data

about an active ingredient in a pesticide product when the application does not seek

a new use of that active ingredient. When read in conjunction with 40 C.F.R.

10 Notably, this regulation applies only to unconditional registrations under FIFRA

Section 3(c)(5) – not conditional registrations under Section 3(c)(7). Thus,

NRDC’s argument in this regard would only pertain to the 2014 and 2015

registration actions, which were unconditional registrations.


28

§ 152.111, “relevant” means that EPA determines whether the “relevant data base”

for a particular “chemical,” i.e., the active ingredient, is being reviewed for

“completeness and scientific validity” in the context of the action being requested.

As explained previously, because glyphosate was already registered for the

same uses that Dow requested in the application for the 2014 and 2015 Enlist Duo

registration actions, the question before EPA in reviewing those applications was

to confirm that these uses were already registered and that any pertinent labeling

requirements were included. EPA therefore complied with 40 C.F.R. § 152.112(b)

when it reviewed “all relevant data in [its] possession” concerning the same or

similar uses for glyphosate and determined that glyphosate should be treated as if it

were a “me-too” registration under 3(c)(7)(A). ER3-4, 84.

For the 2,4-D component of the product, EPA considered the new use for

this ingredient and conducted a full assessment under FIFRA. EPA therefore met

the obligation under its regulation to consider all the relevant data. To determine

that anything more was necessary for the glyphosate in Enlist Duo would

undermine the Congress’ intent behind FIFRA’s conditional registration provision

and registration review process.

The same faulty logic underlies NRDC’s argument that “FIFRA required

EPA to review the evidence of Enlist Duo’s risks to monarchs and humans before

unconditionally approving the pesticide.” NRDC Suppl. Br. 10. Again, this


29

argument pertains only to glyphosate. And NRDC’s reliance on EPA’s regulations

is again misplaced.11 As explained above, there is no requirement that EPA

consider additional data concerning glyphosate because there was no new use

being sought for glyphosate in the Enlist Duo registration or amendments.

Moreover, as EPA explained in its opening brief, the registration review process

for all pesticide products containing glyphosate is the appropriate place for

addressing the concerns and new data about potential risks to monarchs from all

related registrations of glyphosate. See EPA Br. 6-7 (citing glyphosate registration

review).12 This is reasonable and consistent with the statute and EPA’s

regulations.13

11 EPA did review evidence of the risks to monarchs and humans with respect to

2,4-D – the only active ingredient in Enlist Duo for which a new use was being

sought, and the only relevant information as to monarchs and human health EPA

was required to review prior to granting the registration for Enlist Duo. EPA Br.

74-75.

12 NRDC’s own statements about glyphosate in the registration review process

show that NRDC has availed itself of the registration review process as the proper

forum for addresses these concerns. See

https://beyondpesticides.org/dailynewsblog/2019/09/health-and-environmental-

groups-call-on-epa-to-revoke-glyphosates-registration/ (last visited Oct. 7, 2019)

13 NRDC’s reliance on 70 Fed. Reg. at 40,270, is misplaced. NRDC Suppl. Br. 12

(quoting id.) (EPA “must continue to respond to emerging risk concerns and not

defer action until a pesticide’s regularly scheduled registration review.”). The

point of the statement in the Federal Register is that the “action” that should not be

deferred is registering a pesticide product that contains uses already registered.

This is consistent with Congress’ intent not to delay registration actions based on

this evolving science.




30

NRDC further incorrectly relies on 7 U.S.C. § 136d(a)(2). That section

provides that “at any time after the registration of a pesticide the registrant has

additional factual information regarding unreasonable adverse effects on the

environment of the pesticide, the registrant shall submit such information to the

Administrator.” NRDC Suppl. Br. 13. This statutory provision discusses the

registrant’s obligation after receiving a registration. But NRDC has not pointed to

any evidence to show that Dow failed to provide any information required by that

provision.

Finally, NRDC argues that EPA regulations require that the “applicant shall

furnish with his application any factual information of which he is aware regarding

unreasonable adverse effects of the pesticide on man or the environment, which

would be required to be reported under [7 U.S.C. § 136d(a)(2)] if the product were

registered.” NRDC Suppl. Br. 13 (citing 40 C.F.R. § 152.50(f)(3)). EPA does not

disagree with this requirement. However, NRDC never provides any evidence or

citations to particular data that Dow allegedly failed to provide. Even so, that

burden on the applicant does not change the fact that EPA is not required to

continuously review evolving science every time an application is submitted for

the same uses of an already-registered active ingredient.

//

//


31

That Enlist Duo is intended to destroy weeds (including

milkweed) in the field does not render any indirect effects

on monarch butterflies an “unreasonable adverse effect.”

NRDC’s argument that EPA must evaluate indirect effects on monarch

butterflies from destruction of in-field milkweed, NRDC Suppl. Br. 18-19, is really

a dispute about whether EPA must consider, as a potential “unreasonable adverse

effect,” the effect of a pesticide on its target pests listed on the label. Milkweed is

listed as an on-field pest to be controlled by Enlist Duo. FIFRA does not require

that EPA consider whether the pesticide product’s efficacy in controlling the target

pest will have indirect effects. The issue here is whether it is a “reasonable” effect

for Enlist Duo to do what it is intended to do – destroy weeds such as milkweed in

the field. As far as a pesticide goes, the fact that it destroys a particular “pest,” i.e.,

milkweed, is considered a benefit to the use of the pesticide. It is also important to

note that a farmer will get rid of pests (e.g., milkweed) in their fields one way or

another to have the greatest yield of their crop. NRDC’s argument undermines the

entire purpose of a “pesticide product” which is to control pests, including pests

like milkweed.14

//

//

14 Importantly, EPA and other federal agency partners are focusing on a broad

approach to help protect the monarch butterfly. See EPA Br. 77-79.


32

NRDC mischaracterizes EPA’s rationale for not conducting

a new risk assessment for glyphosate.

NRDC’s argument that “EPA must consider new evidence of Enlist Duo’s

harms even if market substitutes pose commensurate risks” mischaracterizes both

the analysis EPA applied to Enlist Duo and the argument presented in EPA’s Brief.

NRDC Suppl. Br. 19-21. NRDC’s assertion that EPA has argued that “Enlist

Duo’s adverse effects are necessarily reasonable if they are not worse than the

harms caused by other pesticides” (id. at 19 (emphasis in original), citing EPA Br.

at 75-76) mischaracterizes EPA’s argument. NRDC’s argument conflates the

regulatory analysis EPA applied to glyphosate (relying on previous assessments

conducted for the same uses of that particular active ingredient) with EPA’s

response to part of NRDC’s argument in its Opening Brief that EPA’s “no

unreasonable adverse effects” finding lacked substantial evidence due to potential

impacts to monarch butterflies via control of on-field milkweed.

As explained above, in determining whether Enlist Duo would cause

“unreasonable adverse effects,” EPA reviewed the application for registration that

requested a new use for 2,4-D and also ensured that the same use for the

glyphosate component was already registered in other existing pesticide products.

Finding that the only new use was for 2,4-D, EPA appropriately only conducted

new assessments for that new use.


33

EPA determined that the glyphosate in Enlist Duo would not cause

unreasonable adverse effects on the environment because the use

conditions authorized under the Enlist Duo registration are identical or

substantially similar to use conditions already authorized for

glyphosate in other existing glyphosate registrations, and the EPA

does not expect the registration of Enlist Duo to significantly change

the locations, methods, or volume of glyphosate used on corn,

soybeans, or cotton.

ER4. That is, since there was no “new use” of glyphosate, EPA reasonably

analyzed the glyphosate component of Enlist Duo as if it were a “me-too”

registration application under FIFRA section 3(c)(7)(A).

Regarding the 2,4-D component of Enlist Duo, NRDC argued in its Opening

Brief that EPA’s analysis of 2,4-D was not supported by substantial evidence, in

that EPA’s findings that 2,4-D had no direct effects on terrestrial invertebrates

(including monarchs) and that 2,4-D would have no off-field effects “skirted the

issue” regarding monarchs due to indirect effects to monarchs via control of on-

field milkweed. NRDC Br. 45-46. In response, EPA explained that NRDC’s

“theory . . . that 2,4-D use through Enlist Duo presumably will increase the effects

on milkweed and, thus, on monarch butterflies” was not supported by the record.

EPA Br. 75. In fact, as noted, the record shows that growers would continue to

control on-field milkweed even without Enlist Duo, because milkweed is not

resistant to glyphosate, and glyphosate is already registered for the same uses. Id.

“[T]he use conditions authorized under the Enlist Duo registration are identical or

substantially similar to use conditions already authorized for glyphosate in other


34

existing glyphosate registrations, and . . . EPA does not expect the registration of

Enlist Duo to significantly change the locations, methods, or volume of glyphosate

used on corn, soybeans, or cotton.” Id. at 76 (citing ER4).

Although EPA cited part of the “no new use” finding from the 2017 Final

Decision Document for the proposition that the record does not support NRDC’s

opening argument that Enlist Duo will increase the destruction of on-field

milkweed, EPA did not find or argue that “Enlist Duo’s adverse effects are

necessarily reasonable if they are not worse than the harms caused by other

pesticides; and EPA need only assess the increment of harm that Enlist Duo poses

beyond the status quo.” NRDC Suppl. Br. 19 (emphasis in original). NRDC’s

supplemental argument in this regard mischaracterizes both EPA’s regulatory

finding and the argument as previously briefed.

Further, NRDC’s statement that “Enlist Duo is more destructive to milkweed

compared to other pesticides because it can be applied later in the growing season”

is misleading. NRDC Suppl. Br. 21. Prior to Enlist Duo, glyphosate was already

registered for control of milkweed later in the season. The registration of Enlist

Duo did not affect the existing registered uses of glyphosate. For 2,4-D, this late-

stage use on these crops was a new use and EPA fully evaluated that new use –

which NRDC does not dispute.


35

Substantial evidence supports the 2017 conditional amendment.

As to the 2017 Amendment, NRDC’s only substantive argument is that EPA

“failed to consider the new evidence of Enlist Duo’s harms to monarchs and

people.” NRDC Suppl. Br. 24. First, NRDC fails to cite any such “new evidence.”

But second, this argument echoes NRDC’s previous argument that EPA failed to

“consider all relevant data” because the Agency did not conduct a new analysis of

all information generated after the 2014 and 2015 registration actions. NRDC

Suppl. Br. 24 (quoting 48 Fed. Reg. at 34,001); NRDC Suppl. Br. 25 (citing 40

C.F.R. § 152.112(b)). This argument is flawed for the same reasons discussed

supra at 27-28 because neither FIFRA nor EPA’s regulations require EPA to

consider new evidence for an active ingredient that has already been registered for

the same uses.

NRDC relies on language from an EPA preamble to argue its point, yet

leaves out pertinent language. NRDC Suppl. Br. 24 (quoting 48 Fed. Reg. at

34,001). The full text of that language (with the portion NRDC leaves out in

italics) provides: “an applicant must provide data showing that his product is

acceptable for registration, including any data specifically required by EPA, and

any other available factual information concerning the adverse effects of the

pesticide on humans or the environment which has not previously been submitted

to the Agency.” Here, the only data required was the data already in existing


36

databases for the same registered uses of glyphosate because Dow did not seek any

new uses for glyphosate. NRDC’s argument demands more of EPA than FIFRA or

the regulations require and would eviscerate the purpose of FIFRA’s registration

review.

Substantial evidence supports EPA’s technical determinations.

The Coalition’s Supplemental Brief largely repeats technical attacks on

EPA’s analyses. None of these arguments has merit. Moreover, EPA deserves

deference on its technical determinations. EPA Br. 58.

EPA’s volatility analysis is supported by numerous valid studies.

EPA previously explained that it reviewed multiple studies to determine that

the 2,4-D in Enlist Duo would not cause unreasonable adverse effects from

volatilization. Id. 50-58. The Coalition’s argument oversimplifies the assessment

necessary to make a determination as to whether there are any alleged volatility

risks of concern for Enlist Duo. Coalition Suppl. Br. 25. To this end, the

Coalition’s characterization tries to ignore the complexities of and the number of

studies EPA considered for its volatility assessment.

After its careful analysis on the issue of volatility, EPA determined that there

were no risks of concern as to volatility. Specifically, “[t]he [Probabilistic

Exposure and Risk Model for Fumigants] model was used to estimate the off-field

distances for various concentrations of 2,4-D as predicted from the vapor flux data


37

. . . [and] [t]he model predicts no adverse damage to plants off-field for any of the

exposure scenarios.” ER647 (emphasis added). The Coalition, however, conflates

drift and volatility.15 It references “2,4-D’s notorious history of causing major drift

damage”16 (emphasis added) and then appears to link that alleged “drift” history to

EPA not providing for a buffer as to “volatility.” Coalition Suppl. Br. 25-25

(emphasis added). EPA, however, did separately assess “drift” potential – which is

distinct from volatility. And EPA imposed a 30-foot downwind buffer to address

any potential issues related to drift.17

The Coalition’s inaccurate arguments regarding the Ouse Study and other

studies, id. at 25, were previously addressed. EPA Br. 50-58. To be clear, the

Ouse study which the Coalition criticizes was neither the only study nor the

definitive study on which EPA relied. Instead, this study provided a reference

15 EPA previously explained the difference. EPA Br. 50, n.17.

16 As to the alleged “notorious history,” EPA has explained that “[t]he Enlist Duo

formulation is labeled with a variety of spray drift mitigation requirements

designed to prevent toxicologically significant levels of exposure in areas off the

treated field where non-target organisms could occur. Additionally . . . the drift

and volatilization properties of this formulation are reduced relative to traditional

forms of 2,4-D products.” ER630.

17 See, e.g., ER640 (noting “label requirement for a 30-foot spray drift,” which is

adequate because “predictions say that there are no concerns for non-target

organisms beyond a distance of 25 feet”); ER642 (“spray drift mitigations on the

current label for Enlist Duo would reduce exposures off site to levels well below

risk concern levels for listed and non-listed species, thereby containing risks to the

treatment site itself.”) (emphasis added); see also, ER34 (requiring “30-foot

downwind in field buffer…”).


38

point for the amount of visual plant damage to sensitive plants from exposure to

2,4-D vapors. EPA Br. 50. But visual plant damage is not the regulatory end point

that EPA used to assess the impacts from Enlist Duo – EPA used visual plant

damage to determine effects on plant growth or survival. Plant growth or survival

is the regulatory end point used. Id. 51-52. Thus, EPA used the Ouse study’s data

regarding the amount of visual plant damage caused by certain doses of 2,4-D

vapor, and translated data into impacts to plant growth or survival. Id. EPA

explained this, along with the limited usefulness of the Ouse study. Id. (citing

ER3190-94). The Coalition ignores all of this, along with all of the additional

studies that EPA used beyond the Ouse study. EPA Br. 52-57 (discussing six field

studies and an additional vapor flux study).18

The Coalition’s argument concerning synergy is unsupported by

the statute and the record, both of which support EPA’s

approach.

The Coalition’s argument concerning tank-mixing and synergy with

glufosinate repeats the same irrelevant argument from its opening brief. Coalition

Suppl. Br. 27-29. The fatal flaw in the Coalition’s argument is that there is no

18 Further, the Coalition provides no record support for its assertion that EPA’s

PERFUM modeling study estimated too small of a field size. Coalition Suppl. Br.

26-27. The Coalition’s statements that the PERFUM modeling was “Dow’s

modeling exercise” and that the model utilizes a field size of “40 acres,” id. 26,

also are incorrect. EPA performed the PERFUM modeling, ER616-617, and the

PERFUM model uses a field size of almost 80 acres, see, e.g., ER715.


39

statutory or regulatory requirement for EPA to assess theoretical combinations in

the field of other registered pesticides with Enlist Duo. EPA Br. 61. Nothing in

the 2014, 2015, or 2017 licenses allows Enlist Duo to be tank-mixed with

glufosinate. A simple reading of Enlist Duo’s label conditions confirms that.

The Coalition is wrong that “to support its registration with substantial

evidence EPA must account for risks from Enlist Duo tank mixes intended for

use.” Coalition Suppl. Br. 27 (citing 7 U.S.C. § 136a(c)(5)(B)). FIFRA Section

3(c)(5)(B), on which the Coalition relies, does not support its argument. The uses

of Enlist Duo “contemplated by the label,” id. at 27-28, do not allow tank-mixing

with glufosinate or any other pesticides that have not undergone specific additional

testing. EPA Br. 61-62. Nothing in FIFRA requires this additional testing prior to

registering or amending a pesticide. Whether or not Dow’s “business plan

strategically involves a third pesticide: glufosinate” is irrelevant. FIFRA does not

require EPA to consider a registrant’s “business plan,” or analyze what other

pesticides the registrant may potentially envision being tank mixed in the future

with the pesticide product undergoing registration or amendment. EPA imposes

label conditions – with which Dow must comply – for any other pesticides Dow


40

may want to tank-mix with Enlist Duo precisely to prevent such expanded

applications.19

EPA Fully Complied With the ESA.

The Coalition reiterates the same flawed ESA mantra that it has been

presenting since 2015 concerning EPA’s levels of concern-risk quotient

methodology: that any overlap between a project’s footprint and a species habitat

necessarily requires ESA section 7 consultation.20 However, its theory hinges

entirely on a misreading of Karuk Tribe, 681 F.3d 1006, and they fail to distinguish

key cases. For example, Friends of Santa Clara River v. U.S. Army Corps of

Eng’rs, 887 F.3d 906 (9th Cir. 2018) (“Santa Clara”) is directly on point.

Additionally, having been unable for four years to identify any actual

impacts to listed species or any meaningful criticism of EPA’s levels of concern-

risk quotient approach, the Coalition cites to several new documents that it now

19 The Coalition’s remaining arguments about glufosinate, tank mixing, and

“synergy,” Coalition Suppl. Br. 27-28 have been fully addressed by EPA. EPA Br.

13-14; see, e.g., ER4-5.

20 EPA incorporates by reference its responses to the Coalition’s claims concerning

EPA’s levels of concern and risk quotient methodology, “no effect”

determinations, and demarcation of the extent of the action area to encompass the

treated fields. Coalition Suppl. Br. at 8-9, 10-13; EPA Br. 78-87, 89-94, 102-05.

The Court previously rejected the Coalition’s motion to stay the Enlist Duo

registration when the Coalition made these same arguments. Ctr. for Food Safety,

et al. v. EPA, Nos. 14-73359, 15-71207 (9th Cir.) (“Enlist Duo I”) (ECF #94).


41

suggests bolster its arguments. However, none of the documents it cites do. Nor

do its mischaracterizations of the 2013 National Academy of Sciences Report

entitled Assessing Risks to Endangered and Threatened Species from Pesticides

(“2013 NAS Report”), SBER001-195, the agencies’ Interim Report to Congress on

Endangered Species Pesticide Evaluation Programs21 (“2014 Interim Report”),

and EPA’s Interim Approaches for National-Level Pesticide Endangered Species

Act Assessments Based on the Recommendations of the National Academy of

Sciences22 (“2013 Interim Approaches Document”), EPA’s recent biological

evaluations (“BEs”) as to chlorpyrifos and malathion, and a 2010 NMFS biological

opinion help it. The latter three are extra-record and irrelevant. The other

documents the Coalition cites support EPA, not the Coalition. These documents

prove that NMFS and FWS (the “Services”) are on the same page as EPA

concerning use of the levels of concern-risk quotient method. The Coalition also

makes claims for the first time concerning glyphosate, but it waived that argument

and lacks standing to assert it. The Court should affirm EPA’s meticulous and

comprehensive ESA “no effect” determinations.

21 2014 Interim Report, available at

https://www.epa.gov/sites/production/fi07/documents/esareporttocongress.pdf (last

visited Oct. 7, 2019). 22 2013 Interim Approaches Document, available at https://www.epa.gov/sites/production/files/2015-07/documents/ interagency.pdf (last visited Oct. 7, 2019).






42

A. The Coalition’s Critique of EPA’s Level of Concern-Risk

Quotient Method is Undercut by This Court’s Jurisprudence.

As a threshold issue, the Coalition’s assessment of relevant precedent to

preclude use of EPA’s levels of concern-risk quotient methodology is

fundamentally flawed. Coalition Suppl. Br. 8-9, 11-12, 16, 18-19, 21 (citing

principally Karuk Tribe). Numerous cases demonstrate that EPA has the latitude

to assess the potential effects of 2,4-D using the levels of concern-risk quotient

method. For example, Santa Clara, which Petitioners do not discuss, is

illustrative. In Santa Clara, the appellants challenged the Army Corps of

Engineers’ (“Corps”) issuance of a Clean Water Act section 404 permit to a large

development project. The permit at issue authorized the discharge of copper into

the Santa Clara River. 887 F.3d at 906. As part of the Corps’ ESA assessment, the

agency considered the project’s potential to affect listed steelhead and the species’

downstream habitat through increased stormwater discharges. Id. at 915-16.

The fact that the project’s footprint overlapped with steelhead habitat

notwithstanding, the Court affirmed the Corps’ “no effect” determinations.23 Id. at

23 Similar to the plaintiffs’ allegations against the Corps in Santa Clara, here the

Coalition maintains that EPA failed to consider an agency document that they

believe represents the best available science. Coal. Suppl. Br. 3-5, 6-7, 14-15, 20-

23. The Santa Clara appellants contended that the report established that sublethal

impacts to steelhead smolts could occur at the levels of dissolved copper flowing

from project discharges. Santa Clara at 924. This Court disagreed, recognizing

that the determination of what constitutes the “best scientific data available”


43

923-26. The Court credited the Corps’ data and analysis, which established that

concentrations of dissolved copper in discharges would fall within the background

range already observed in the river and well below the EPA’s dissolved-copper

criterion for the river. Id. at 924.24

The Coalition’s failure to mention, much less distinguish, Santa Clara is not

the only flaw in its analysis. Its argument also rests entirely on a fundamental

mischaracterization of Karuk Tribe. Coalition Suppl. Br. 40-41, 54, 68. The

Coalition cites to language in Karuk Tribe to suggest that “actions that have any

chance of affecting listed species” require consultation. Id. at 40 (emphasis in

original) (quoting Karuk Tribe); see also id. at 54 (same), 68 (same argument

concerning effects to critical habitat). The Coalition suggests that any “possible”

effect–as in any “risk” of an effect, or any “hypothetical” “hypothesized” effect, is

“all that is required to compel consultation.” Coalition Suppl. Br. 19.

The problem for the Coalition is that Karuk Tribe did not create such an

illogical standard. Such a reading would be inconsistent with the ESA’s

implementing regulations, stripping action agencies of the ability to make “no

belongs to the agency’s “special expertise[’]” and warrants deference. Id. at 924-

25. The Court should, as it did in Santa Clara, decline to substitute its scientific

judgment for that of EPA. 24 See EPA Br. 80-83, 95, regarding additional cases supporting EPA’s argument

that EPA has the latitude to use its level of concern methodology at the first of

stage of ESA consultation.


44

effect” / “may affect” determinations under 50 C.F.R. § 402.14(a). That regulation

creates a division of labor between action and consulting agencies and requiring

consultation only where an agency action actually “may affect listed species or

critical habitat.” Id. (emphasis added). As this Court stated in California ex rel.

Lockyer, “[a]n agency’s finding that its action will have no effect on listed species

or critical habitat obviates the need for consultation.” 575 F.3d 999, 1019 (9th Cir.

2009) (quoting Sw. Ctr. For Biological Diversity v. U.S. Forest Serv., 100 F.3d

1443, 1447-48 (9th Cir. 1996)). Karuk Tribe did not negate 50 C.F.R. § 402.14.

The Coalition’s theory would improperly obliterate the distinction between no

effect and may effect.

The factual context further supports EPA. In Karuk Tribe, unlike here, there

was no meaningful dispute that the activity at issue, suction dredge mining, would

have measurable effects. A government biologist’s report in the record stated that

effects included, inter alia, (a) mortality via entrainment; (b) streambed

destabilization; (c) decreases in reproductive success; (d) alteration to surface

substrate composition; and (e) reduction of microhabitat availability due to

sediment deposition. Karuk Tribe (ECF #27 at 9-12). The only argument about

effects, which the Intervenors (not the government) made in one page in their brief,

relied on extra record documents. Karuk Tribe (ECF #36 (Intervenor’s answering

brief) at 36-37; ECF #41 (Appellants’ reply) at 31). The Court in Karuk Tribe had


45

before it concrete, discernible effects, not a mere “possible risk.” Cf. Coalition

Suppl. Br. 41, n.19.

Indeed, the gravamen of Karuk Tribe was not about the nature or extent of

any effects to species, but rather the extent to which U.S. Forest Service retained

discretionary involvement and control over the action at issue giving rise to an

ESA obligation. Karuk Tribe, Case No. 05-16801 (9th Cir.) (ECF #27 at 15-17,

29-38; ECF #27 at 3 (no dispute USFS declined to conduct ESA analysis because

it did not consider the action to be an “agency action” triggering ESA obligations,

id. at 27-36). The Court should reject the Coalition’s attempt to manufacture a

new rule requiring consultation any time there is any overlap between a project’s

footprint and a species’ habitat.25

B. The Court Should Defer to the Services and the EPA, not the

National Academy of Sciences, as to Which Methodology

Represents the “Best Available Science.”

The Coalition contends that the 2013 NAS Report criticized the level of

concern-risk quotient approach and the Court should therefore find EPA acted

arbitrarily and capriciously. Coalition Suppl. Br. 4-6, 21-23. It maintains that the

25 The Coalition argues that EPA’s assessment was too “narrow” and should have

included inert ingredients of Enlist Duo, such as surfactants. Coal. Suppl. Br. at

72. This argument fails because the Coalition does not identify any inert or

surfactant that EPA allegedly did not consider or that is causing any “direct or

indirect effects” on listed species or critical habitat. Id.; 50 C.F.R. § 402.13.


46

2013 NAS Report serves as the “gold standard” and embodies the best available

science on how to conduct ESA pesticide assessments.26 Id. at 21-23.

The Coalition’s argument lacks merit.27 The decision as to how to

harmonize FIFRA and the ESA and conduct pesticides consultations is for EPA

and the Services, not the NAS, to decide. Coalition Br. 8, n.8 (Coalition arguing

that “Congress assigned FWS the job of ESA implementation, and as such FWS is

entitled to deference . . . .”). Neither Congress nor the Services or EPA has

delegated the agencies’ responsibility to interpret FIFRA or the ESA to the NAS.

Lombardo v. Handler, 397 F. Supp. 792, 793 (D.D.C. 1975), aff’d 546 F.2d 1043

(D.C. Cir. 1976) (NAS is not an “agency” under the APA). The Coalition’s

reliance on the 2013 NAS Report is misplaced.

26 In nine briefs on this issue, the Coalition has returned to the same mantra

concerning the level of concern-risk quotient issue. ECF #79, 85, 170; Enlist Duo

I (ECF #32, 36, 55); Nat’l Family Farm Coal., et al. v. EPA, No. 17-70196 (9th

Cir.) (“Dicamba I”) (ECF #70-1, 133); Nat’l Family Farm Coal., et al. v. EPA, No.

19-70115 (9th Cir.) (“Dicamba II”) (ECF #35). Not once has it identified any

observable effect to any listed species or critical habitat. Id.

27 The Coalition cursorily reiterates its objections to the manner in which EPA

analyzed potential effects to two species, and its critical habitat argument, without

further elucidating its flawed allegations. ECF #170 at 13, 20, n.15. EPA

incorporates by reference its previous arguments as to those species and critical

habitat. ECF #83 at 94-102; 105-10; see also Weyerhauser v. FWS, 139 S. Ct. 361,

368 (2018) (explaining that areas designated as critical habitat must also be actual

habitat for the species).


47

In any event, the Services and EPA have appropriately considered that report

and incorporated it into their deliberations in light of their decades of collective

experience with pesticide consultations.28 In March 2011, EPA, on behalf of itself,

the Services and USDA, requested that a committee of the NAS convene to

examine scientific and technical issues associated with determining the risk of

pesticide registration and use to threatened and endangered species protected by

the ESA. RER621. The agencies asked the NAS for advice on a range of subjects

related to risk assessment and the ESA Section 7 consultation process. Id.

On April 30, 2013, the Academy provided its recommendations to the

agencies. RER910. The NAS assessed the Services’ and EPA’s risk assessment

methodologies and did not discount the usefulness of analysis of exposures,

species responses to such exposures, estimated environmental concentration levels,

or toxicity thresholds. SBER27 (exposure concentrations)29; SBER31 (species

respond differently to chemical exposures); SBER052 (toxicity thresholds);

SBER068 (estimated environmental concentrations); SBER112 (chemical

concentrations). The NAS recommended what it called a “probabilistic approach.”

28 Unlike in other instances, Congress has not provided any particular direction to

the Services and EPA as to how, or whether, to implement the 2013 NAS Report.

Cf. City of L.A. v. U.S. Dep’t of Commerce, 307 F.3d 859, 878 (9th Cir. 2002)

(discussing statute requiring agency to take NAS’s findings into account).

29 “SBER” refers to the Coalition’s Supplemental Brief Excerpts of Record.


48

SBER169-171. The NAS explicitly cabined its analysis, however, by stating that

“[d]ecisions about acceptable levels of risk and how to manage risk are policy

decisions that are not part of the scientific analysis.” SBER063. NAS also

recognized “the pragmatic demands of the pesticide-registration process” and the

fact “that administrative and other nonscientific hurdles will need to be overcome

to implement this approach . . . .” SBER034. The NAS envisioned coordination

discussions among the agencies would occur on issues such as new approaches for

exposure and effects analysis. SBER054.

While the Coalition elides this backstory, the coordination discussions the

NAS envisioned have been occurring since 2013 and fully rebut the Coalition’s

dated argument. 2014 Int. Rep. at 4. Consistent with the 2013 NAS Report, the

agencies have been collaborating to develop shared scientific approaches that

reflect the advice provided. Id. at 4. As part of this process, the agencies

published their Interim Report to Congress in November 2014. The agencies made

clear that the Interim Approaches discussed in the Interim Report is not meant to

be applied to all registration decisions. Id. at 21. The application of the Interim

Approaches is an iterative process to be applied to certain pesticides as a pilot

process, before applying this process to all pesticides. The Interim Report stated

that EPA would complete compliant endangered species assessments in accordance

with its 2004 Overview Document for all new herbicide tolerant crop uses and that


49

the Overview Document is the basis for EPA’s ecological assessments for all

chemicals other than chlorpyrifos, diazinon, malathion, carbaryl, and methomyl.

Id. at 21, 22; RER917-18; RER3. 2,4-D was not one of the pilot chemicals to

which the Interim Approaches would apply. Thus, FWS and NMFS, the agencies

that the Coalition refers to as the “expert” agencies, espoused the use of the levels

of concern/risk quotient approach for 2,4-D. The Interim Report went on to

observe that EPA had recently registered Enlist Duo, EPA “scientists used highly

conservative and protective assumptions to evaluate ecological risks for the new

uses of 2,4-D.” Id. at 21. It stated that Enlist Duo use “will be protective of non-

target species, including endangered species.” Id.

C. The Court Should Not Rely on the Extra-Record Biological

Opinion and Evaluations that the Coalition Cites.

In its attempt to undermine the level of concern-risk quotient approach, the

Coalition also cites to an extra-record 2010 NMFS biological opinion and two

extra-record BEs assessing potential effects of chlorpyrifos and malathion.

Coalition Suppl. Br. 7 (EPA BEs) 15, n. 12 (2010 NMFS Biological Opinion). The

Coalition reasons as to the latter that EPA made a number of “may affect” or

“likely to adversely affect” determinations in those evaluations, and should have

made more here. Id. at 7.

The Coalition’ argument fails for several reasons. As a threshold matter, the

Coalition’s argument is based on an extra-record material. The Court’s review of


50

the Coalition’s claims is limited to the Administrative Record before the agency at

the time of its decision. Fla. Power & Light Co. v. Lorion, 470 U.S. 729, 743-44

(1985); Lands Council v. Powell, 395 F.3d 1019, 1030 (9th Cir. 2005). While the

Coalition has made requests to add documents to the Administrative Record in this

case in the past, here it did not do so. The Court should decline to rely on those

documents, which were not considered by or relevant to the decision made by

EPA.30

And in any event, any wisdom that could have been gleaned from the 2010

NMFS biological opinion that the Coalition cites, has been negated by the

agencies’ 2014 Interim Report to Congress. NMFS issued the 2010 biological

opinion four years before EPA and the Services established that EPA would

continue to use the levels of concern-risk quotient approach. Supra at 48-49

(discussing 2014 Int. Rep. at 21-22). The agencies decided that going forward,

EPA would employ the levels of concern-risk assessment approach for use on all

but a handful of pesticides consultations. Id. (same). 2,4-D was not one of those.

30 To the extent the Court is inclined to consider extra record biological opinions,

EPA’s objection notwithstanding, NMFS frequently uses the same concepts as

EPA, such as Lethal Concentration (“LC50”) and Lowest Observed Effect

Concentration in its biological opinions. NMFS, Biological Opinion Concerning

the EPA’s Registration of Pesticides Containing Chlorpyrifos, Diazinon, and

Malathion (2008), at 272, 277, 278, 279, 291, available at

https://www.fisheries.noaa.gov/national/consultations/pesticide-consultations.


https://www.fisheries.noaa.gov/national/consultations/pesticide-consultations

51

Id. The 2010 NMFS biological opinion therefore antedates the agencies’ decision

on how best to proceed and does not undermine EPA’s use of the levels of

concern-risk quotient approach in any way. Santa Clara 887 F.2d at 924

(deferring to Corps’ technical expertise as to question concerning consideration of

sublethal effects).

As to EPA’s chlorpyrifos and malathion BEs, EPA and the Services agreed

in 2014 that EPA would use a different methodology, the Interim Approaches, for

assessing chlorpyrifos and malathion.31 The Court should reject the Coalition’s

attempt to confuse the issue by claiming EPA had to follow the same approach

here as it followed with respect to chlorpyrifos and malathion.

D. The Coalition Waived and Lacks Standing to Raise, and the

Court Lacks Jurisdiction to Consider, its New Glyphosate

Argument.

The Coalition’s new claim that EPA’s assessment of Enlist Duo was

“incomplete” because it did not assess glyphosate is barred. Coalition Suppl. Br.

20-21. As an initial matter, the Coalition waived this argument by not raising it in

its opening brief. Rizk v. Holder, 629 F.3d 1083, 1091, n.3 (9th Cir. 2011) (a

31 EPA, Biological Evaluation Chapters for Chlorpyrifos ESA Assessment, at 4-43 (discussing use of probabilistic approach), available at https://www.epa.gov/endangered-species/biological-evaluation-chapters-chlorpyrifos-esa-assessment; EPA, Biological Evaluation Chapters for Malathion ESA Assessment, at 4-23 (same), available at https://www.epa.gov/endangered-species/biological-evaluation-chapters-malathion-esa-assessment (last visited Oct. 8, 2019).






52

petitioner waives issue by failing to raise it in its opening brief). The Coalition is

incorrect when it suggests that “none of [its] challenges [have] fundamentally

change[d].” Coalition Suppl. Br. 2.

The Court stated in its May 30, 2019, order that “[i]n their briefing, the

parties should address all challenges to the initial registration (2014 order) and the

original amendment (2015 order), as that registration and amendment has been

reissued in the 2017 order—including challenges to all supporting documentation.”

ECF #166 at 8 (emphasis added). That Order concerned a jurisdictional argument

EPA had made about the 2014 initial registration and 2015 original amendment.

Id. EPA interprets the words “all challenges” to mean arguments already raised in

the parties’ opening and answering briefs, not “all challenges that the parties have

raised or wish to raise now for the first time.”

But even if the Court did so intend, the Coalition lacks standing to challenge

EPA’s actions as to glyphosate. To establish Article III standing, a claimant must

show “(1) it has suffered an ‘injury in fact’ that is (a) concrete and particularized

and (b) actual or imminent, not conjectural or hypothetical; (2) the injury is fairly

traceable to the challenged action of the defendant; and (3) it is likely, as opposed

to merely speculative, that the injury will be redressed by a favorable

decision.” Friends of the Earth, Inc. v. Laidlaw Envtl. Servs. (TOC), Inc., 528 U.S.

167, 180-81 (2000) (citing Lujan v. Def. of Wildlife, 504 U.S. 555, 560-61


53

(1992)). Additionally, the Coalition may assert standing on behalf of its members

as long as the “members would otherwise have standing to sue in their own right,

the interests at stake are germane to the organization’s purpose, and neither the

claim asserted nor the relief requested requires the participation of individual

members in the lawsuit.” Id. at 181.

Here, the Coalition has not shown that it or its members have suffered an

injury that is fairly traceable to the glyphosate component of EPA’s registration

decisions for Enlist Duo, or that any alleged injury would be redressed by a

favorable decision. The Coalition attached seven declarations to its opening brief.

The Coalition cannot rely on two of those, from Mssrs. Buse and Suckling,

because they are members of two of the Petitioners, Pesticides Action Network of

North America (“PANNA”) and the Center for Biological Diversity, that have

already entered into a settlement agreement with EPA on this issue. Ctr. for Biol.

Div., et al. v. EPA, No. 07-cv-2794 (N.D. Cal.) (“Bay Area Pesticides”). Under

that agreement, EPA is scheduled to complete review of glyphosate as part of

registration review in June 2020. Id. (ECF #74).32 PANNA and the Center for

32 EPA recently renegotiated its June 2020 date from Bay Area Pesticides with the

Center for Biological Diversity and PANNA in a draft pesticides settlement

agreement. 84 Fed. Reg. 44,297 (Aug. 23, 2019); Ctr. for Biol. Div., et al. v. EPA,

No. 3:11-cv-293 (N.D. Cal.) (ECF #358, 360). In it, the plaintiffs and EPA

recognize that EPA will complete its BE for glyphosate in June 2021, not June

2020. The comment period closed on that draft settlement agreement on September


54

Biological Diversity are barred from relitigating the deadline for consultation on

glyphosate here. Tritz v. U.S. Postal Serv., 721 F.3d 1133, 1141 (9th Cir. 2013)

(“[c]ourt-approved settlement agreements . . . have res judicata effect.”).

Nor can the Coalition rely on any of the other declarations from National

Family Farm Coalition, PANNA, Beyond Pesticides, or the Center for Food Safety

declarants. The declarations of Ms. Eitemann (¶¶ 8-9) (Nat’l Family Farm

Coalition), Ms. Crouch (¶¶ 12-13) (Beyond Pesticides), and Mssrs. Feldman (¶¶ 2,

4-5, 7-10), Kimbrell (paras. 2, 9, 11) (Ctr. for Food Safety), and Pool (¶¶ 9, 10-14,

16) (Nat’l Family Farm Coalition), all discuss the use of 2,4-D on treated fields,

not glyphosate. ECF #64-1 at A92-155. Apparently the Coalition did not intend to

assert a challenge regarding glyphosate when filing its opening brief, and therefore

did not file declarations supporting such a challenge. Id. at 5, 7 (opening brief

discussing 2,4-D, not glyphosate); 26-1 at 1 (Coalition discussing 2,4-D use but not

mentioning glyphosate).

23, 2019. Ctr. for Biol. Div. and PANNA v. EPA, No. 3:11-cv-293 (N.D. Cal.)

(ECF #360). None of the Coalition Petitioners commented on that settlement

agreement. EPA, Docket for Center for Biol. Div., et al. v. EPA, 3:11-cv-293

(N.D. Cal.), available at https://www.regulations.gov/ docket?D=EPA-HQ-OGC-

2019-0478 (last visited Oct. 8, 2019). The Court should allow EPA and the

Services to complete the glyphosate consultation process in conjunction with the

registration review process, as contemplated by EPA, the Center for Biological

Diversity and PANNA.




55

The Coalition also fails to demonstrate causation. As discussed above,

glyphosate has been registered in other pesticide products for the same use as is

contemplated here since the 1990s. Supra at 5-8, 12, 22-30. Thus, the registration

decisions changed nothing with respect to how, when, where, and how much

glyphosate is or will be used going forward. Glyphosate is presently being applied

in the same fields where Enlist Duo applications would be expected, using the

same application methods as registered for Enlist Duo. Id. Accordingly, there is

no probative link between EPA’s decision to register Enlist Duo and any ESA

listed species based on its registration of glyphosate. Lujan, 504 U.S. at 560

(“injury has to be ‘fairly . . . traceable to the challenged action of the defendant,

and not . . . the result of the independent action of some third party not before the

court’”) (citation omitted). Thus, the Coalition cannot demonstrate the “injury” or

“causation” prongs of Article III standing.

The Coalition additionally cannot meet the third prong of the Article III

standing inquiry, redressability. “Redressability depends on whether the court has

the ability to remedy the alleged harm.” Nuclear Info. & Res. Serv. v. NRC, 457

F.3d 941, 955 (9th Cir. 2006). Here, even if the Court rules in the Coalition’s

favor on the merits of its substantive challenges to the glyphosate in Enlist Duo,

the ruling would not redress its perceived harm to listed species posed by

glyphosate. Other pesticide products containing glyphosate would continue to be


56

sold, distributed, and used on these same crops in accordance with the previously

approved registrations that authorized these uses since the 1990’s. See id. (holding

that petitioners had failed to establish redressability when there was an existing

regulation); cf. Coalition Suppl. Br. 33 (contending use of 2,4-D would increase,

but the volume of glyphosate would remain the same). Thus, as discussed further

below, the Coalition’ opportunity for redressability as to glyphosate use is not

through a challenge to Enlist Duo. Rather, the more appropriate avenue through

which the Coalition potentially could redress its alleged injuries from glyphosate is

through the FIFRA Section 3(g) registration review process, where the uses of

glyphosate across all registered pesticide products will be reviewed. Indeed, as

noted above, two of the Coalition Petitioners–the Center for Biological Diversity

and PANNA–are pursuing this avenue. Bay Area Pesticides (ECF #74).

In any event, such a challenge would lack merit. The Coalition’s challenge

as to glyphosate assumes that there exists an agency action triggering ESA section

7 obligations. But for that to be true, the Coalition would first have to show that

EPA was required to conduct a new assessment for glyphosate under FIFRA. See

supra at 5-8, 12, 22-30; 16 U.S.C. § 1536(a)(2). They cannot do this because

Enlist Duo does not require any “new use” of glyphosate. EPA has not

“authorized,” “funded” or “carried out” any action with respect to glyphosate in

authorizing Enlist Duo. Id. And the Coalition’ arguments about generalized


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glyphosate effects and usage do not give rise to any ESA claim. Ctr. for Biol. Div.,

et al. v. EPA, 847 F.3d 1075, 1091 (9th Cir. 2017) (because appellants Center for

Biological Diversity and PANNA “fail[ed] to identify an affirmative

agency action [taken pursuant to FIFRA] that would trigger a Section 7

consultation, we affirm the district court’s dismissal . . . .”). The Court should

therefore reject the Coalition’s claims as to glyphosate and affirm EPA’s

comprehensive ESA assessments. EPA Br. 78-109.

If the Court Grants Any Aspect of the Petitions for Review, the Proper

Remedy is Remand Without Vacatur.

EPA’s opening brief discussed the relevant standards for vacatur, which no

Petitioner has met. EPA Br. 110-11. Here, if the Court grants any aspect of the

petitions for review, the Enlist Duo registration should remain in effect during any

remand.

First, the disruptive consequences of vacatur on the farmers using Enlist Duo

warrant remand only.33 NRDC’s claim that farmers have other “weed management

tools available” misses the mark. NRDC Suppl. Br. 26. As Dow will illuminate,

farmers already have invested in both Enlist Duo and seeds that are resistant to

Enlist Duo. Thus, what NRDC demands is that those farmers be precluded from

using the seeds and pesticide that they have already purchased and expend

33 EPA understands that these repercussions on farmers will be more fully

explained in Dow’s supplemental brief.


58

additional money on alternative seeds and pesticides. Such a consequence is an

overwhelming disruption for those farmers. “Equity demands” that such disruption

not occur, Idaho Farm Bureau Federation v. Babbitt, 58 F.3d 1392, 1405 (9th Cir.

1995), and these disruptive consequences outweigh the public health and

environment concerns (which, for the reasons discussed above, are not supported

by evidence) on which Petitioners rely. NRDC Suppl. Br. 27-28; Coalition Suppl.

Br. 33. Moreover, any procedural defects are more appropriately addressed

through remand without vacatur.

Similarly, as to the ESA issues, to extent the Court finds that EPA’s Step 1

(“no effect” / “may affect”) analysis did not consider a potential effect to a

particular species, rendering EPA’s analysis arbitrary and capricious, EPA would

be able to remedy that violation by further explicating its reasoning. As such, an

injunction is not warranted.

Finally, the cases on which Petitioners rely do not support vacatur in this

case. For example, Pollinator Stewardship Council v. EPA, 806 F.3d 520 (9th Cir.

2015) contains a key statement that distinguishes that case from this situation.

There, the Court’s key statements supporting vacatur were the “precariousness of

bee populations” and the fact that “on remand, a different result may be reached.”

Id. at 532. Setting aside the fact that the Court did not discuss any balancing of

disruptive consequences against the concerns over the bee population, the more


59

telling fact is that the Court determined EPA may reach a different result on

remand. Here, Petitioners have not shown any evidence or made any argument to

support that EPA may reach on different result on remand with respect to Enlist

Duo, i.e., that EPA would decide not to issue the Enlist Duo registration or even

that EPA would impose additional conditions on Dow as the registrant (nor have

Petitioners actually argued that any additional conditions should be placed on

Dow). Indeed, there is nothing to support the notion that any of the “fundamental

flaws” argued by Petitioners “make it unlikely that the same [action] would be

adopted on remand.” Id. The fact that EPA likely would re-issue the Enlist Duo

registration, combined with the disruptive consequences to farmers, undermines

Petitioners’ demand for vacatur.34

CONCLUSION

For the foregoing reasons and those stated in EPA’s opening brief, EPA

//

//

//

//

34 Further, neither of the other cases on which NRDC relies support vacatur

because the Court did not address the disruptive consequence of vacatur, which is a

pertinent issue here. See NRDC Suppl. Br. 26 (citing NRDC v. EPA, 857 F.3d

1030, 1042 (9th Cir. 2017); NRDC v. EPA, 735 F.3d 873, 884 (9th Cir. 2013).


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requests that the Court deny the petitions for review.

Respectfully submitted,

JONATHAN D. BRIGHTBILL

Principal Deputy Assistant Attorney General

JEAN E. WILLIAMS

Deputy Assistant Attorney General


Division

/s/ Michele L. Walter

MICHELE L. WALTER

Trial Attorney



Division

Environmental Defense Section

999 18th St.

South Terrace, Suite 270

Denver, Colorado 80202

(303) 844-1345

/s/ J. Brett Grosko

J. BRETT GROSKO

Senior Trial Attorney



Division

Wildlife and Marine Resources Section

P.O. Box 7611


(202) 305-0342

Counsel for Respondents


61

Of counsel

Benjamin Wakefield

Michele Knorr

U.S. Environmental Protection Agency

Office of General Counsel

Pesticides & Toxics Substances Law Office

1200 Pennsylvania Avenue, NW


Dated: October 11, 2019


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CERTIFICATE OF COMPLIANCE

I hereby certify that this brief complies with the requirements of Fed. R.

App. P. 32(a)(5) and (6) because it has been prepared in 14-point Times New

Roman, a proportionally spaced font.

I further certify that this brief complies with the type-volume limitation of

Fed. R. App. P. 32(a)(7)(B) and Circuit Rule 32-1 because it contains 13,996

words, excluding the parts of the brief exempted under Rule 32(a)(7)(B)(iii),

according to the count of Microsoft Word.


MICHELE L. WALTER


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CERTIFICATE OF SERVICE

I hereby certify that on October 11, 2019, I electronically filed the foregoing

brief with the United States Court of Appeals for the Ninth Circuit by using the

CM/ECF system. I certify that all case participants are registered for the Appellate

CM/ECF System and that they will be served by the CM/ECF system.


MICHELE L. WALTER
